Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorInstitute of Oncology Ljubljana
About this trial
The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer patients with DCIS with an indication for adjuvant radiation therapy
Disqualifiers
Any specific systemic oncological therapy
Trial population
Breast cancer patients with non invasive ductal carcinoma in situ (DCIS) with an indication for postoperative radiation treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Adverse events of radiation therapy
We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging
Time frame
Within 1 month after completion of radiotherapy2
Adverse events of radiation therapy
We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging
Time frame
6 months after radiotherapy3
Adverse events of radiation therapy
We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging
Time frame
2 years after radiotherapy4
Adverse events of radiation therapy
We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging
Time frame
5 years after radiotherapySecondary outcomes
1
Disease recurrence
We will assess the proportion of patients with disease recurrence.
Time frame
5 years after radiotherapy2
Disease recurrence
We will assess the proportion of patients with disease recurrence.
Time frame
10 years after radiotherapy3
Changes of circulating biomarkers
We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.
Time frame
Within 1 month after completion of radiotherapy4
Changes of circulating biomarkers
We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.
Time frame
6 months after radiotherapy,Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Oncology Ljubljana
Lead sponsor
University of Ljubljana, Faculty of Medicine
Collaborator
University Medical Centre Ljubljana
Collaborator
Source ClinicalTrials.gov